{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192319",
      "product_res_number": "Z-0747-2022",
      "event_date_initiated": "2022-02-15",
      "event_date_created": "2022-03-10",
      "recall_status": "Open, Classified",
      "res_event_number": "89731",
      "product_code": "LHN",
      "k_numbers": [
        "K163500"
      ],
      "product_description": "ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation\nProteus 235",
      "code_info": "PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109 (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK), SBF.117 (EU), SBF.128 (US).  UDI: (01)05404013801138",
      "firm_fei_number": "3000256071",
      "recalling_firm": "Ion Beam Applications S.A.",
      "address_1": "Chemin Du Cyclotron 3 3 chemin du cyclotron",
      "city": "Louvain-la-neuve",
      "country": "Belgium",
      "reason_for_recall": "When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range",
      "root_cause_description": "Device Design",
      "action": "IBA issued  Urgent Medical Device Correction notification on February 15, 2022  directly to customer either by hand or by email. Letter states reason for recall, health risk and action to take:\nFor Proton Therapy sites where the system is operated by the customer:\n- Warn operators to not manually change the beam range (action called manual  set range ) while a patient is on the Patient Positioning System.\n- IBA will provide a training to all operators about the correct use of the action called manual  set range  and the risk associated to its use while a patient is on the Patient Positioning System. This training will be provided on your site by August 31, 2022.\n\nContact: Vigilance@iba-group.com.\nHelp Desk: +32 2 507 20 81 (available 24/7)",
      "product_quantity": "15 units US; 22 units OUS",
      "distribution_pattern": "IL, KS, LA,  FL, MI, OK, PA, NJ,  TN, TX, VA, WA \nForeign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South  Korea, Taiwan, Netherlands,",
      "openfda": {
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          "K983342",
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          "K112981",
          "K232032",
          "K860606",
          "K221996",
          "K112768",
          "K073059",
          "K093250",
          "K153614",
          "K120676",
          "K973960",
          "K243900",
          "K053641",
          "K981358",
          "K191801",
          "K201042",
          "K160432",
          "K112969",
          "K191821",
          "K260174",
          "K080886",
          "K200282",
          "K061913",
          "K062891",
          "K163500",
          "K242418",
          "K032886",
          "K061152",
          "K101508",
          "K132847",
          "K250986",
          "K231863",
          "K083058",
          "K152592",
          "K972211",
          "K953391",
          "K151132",
          "K133191",
          "K152224",
          "K982937",
          "K080799",
          "K191521",
          "K032511",
          "K134052",
          "K053280",
          "K124002",
          "K221791",
          "K052118",
          "K060695",
          "K061051",
          "K851301",
          "K981112",
          "K082416",
          "K983629",
          "K253406"
        ],
        "registration_number": [
          "9613183",
          "1038814",
          "3016872563",
          "3010658895",
          "8043933",
          "1062572",
          "3007087027",
          "2247992",
          "3015178562",
          "2032229",
          "3042022819",
          "3004977335",
          "3008317830",
          "3009754495",
          "3010726836",
          "8031557",
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          "3003993895",
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          "9681124",
          "3000256071",
          "1000162206",
          "9614952",
          "1721113",
          "3015232217"
        ],
        "fei_number": [
          "3006653576",
          "3001874253",
          "1038814",
          "3007360740",
          "3016872563",
          "3010658895",
          "3002619595",
          "3007087027",
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          "1000227792",
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          "3003166990",
          "3000256071",
          "1000162206",
          "3001238439",
          "1721113",
          "3015232217"
        ],
        "device_name": "System, Radiation Therapy, Charged-Particle, Medical",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5050",
        "device_class": "2"
      }
    }
  ]
}